Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
FDA 510(k) K232286 · Quidel Corporation
510(k) numberK232286
Submission
- Device name
- Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- Applicant
- Quidel Corporation
San Diego, CA, US - Received
- August 1, 2023
- Decision date
- December 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGI – Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3309
- Specialty
- Microbiology
For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
Other 510(k)s with product code PGI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233349 | Alinity m HSV 1 & 2 / VZVPGI · Traditional | Abbott Molecular, Inc. | 05/03/2024SE |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI · Traditional | Diasorin Molecular, LLC | 11/26/2019SE |
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusPGI · Traditional | Elitechgroup | 10/29/2018SE |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackPGI · Traditional | Diasorin Molecular, LLC | 03/14/2018SE |
| K162451 | Solana HSV 1+2/VZV AssayPGI · Traditional | Quidel Corporation | 11/28/2016SE |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File…PGI · Traditional | Luminex Corporation | 10/06/2015SE |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit…PGI · Traditional | Meridian Bioscience, Inc. | 07/17/2015SE |
More from Meridian Bioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231795 | QuickVue COVID-19 TestQYT · Traditional | 03/22/2024SE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | 12/13/2023SE |
| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | 03/03/2023SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | 08/30/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | 07/15/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
| K180288 | QuickVue Influenza A+BPSZ · Special | 02/13/2018SE |
| K173250 | Solana GBS AssayNJR · Traditional | 12/21/2017SE |
Questions and answers
When was Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument cleared by the FDA?
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (K232286) received a 510(k) decision of Substantially Equivalent on December 20, 2023, 141 days after the submission was received.
What is the product code of K232286?
The FDA product code is PGI – Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples, a Class II (moderate risk) device regulated under 21 CFR 866.3309.